NCT07636590
Multi-Center, Prospective, Non-Interventional Study in Subjects With Limbal Stem Cell Deficiency
Recruiting
Not specifiedAges 12–99ObservationalClaris Biotherapeutics, Inc.
~500 participants
Updated 2026-07-28 on ClinicalTrials.gov
What's tested:Non-interventional
At a glance
Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Natural Progression of LSCD as Assessed by Changes in Patient Reported Outcomes
Measured over Screening through Week 84
+5 more outcomes measured
Conditions
Where it's being run
2 sites across 1 statesIndiana2
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
A photopic BCVA in the prospective study eye(s) of ≤ 70 letters at the Screening and Day 1 visits AND a change of ≤ 10 letters in photopic BCVA at Day 1 compared to the Screening Visit
Qualifying LSCD diagnosis in the study eye(s) prior to enrollment at Day 1
Written confirmation that exclusions on retinal findings are met in the study eye(s) prior to enrollment at Day 1
Inflammation associated with LSCD or other non-infectious inflammation (e.g., dry eye, ocular rosacea, and blepharitis) that will not interfere with the subject's participation in the opinion of the investigator is permitted.
Exclusion
Any active ocular infection in either eye at either the Screening or Day 1 visits
Active sterile iritis or uveitis in either eye at Screening or Day 1 visits
Screening visit retinal exam finding, in the opinion of the investigator, that would limit potential for visual acuity gain in the study eye(s)
What this trial measures
- Natural Progression of LSCD as Assessed by Changes in Patient Reported OutcomesScreening through Week 84
Onset or changes (worsening or improving) in vision-related quality of life and ocular symptoms as captured with the National Eye Institute Visual Function Questionnaire-25 (VFQ-25) and Ocular Surface Disease Index (OSDI) questionnaires
- Natural Progression of LSCD as Assessed by Functional Changes (Photophobic BCVA)Screening through Week 84
Change in photophobic BCVA
- Natural Progression of LSCD as Assessed by Functional Changes (Low-luminance BCVA)Screening through Week 84
Change in low-luminance BCVA
- Natural Progression of LSCD as Assessed by Functional Changes (Low-contrast BCVA)Screening through Week 84
Change in low-contrast BCVA
- Natural Progression of LSCD as Assessed by Functional Changes (Contrast Sensitivity)Screening through Week 84
Change in contrast sensitivity (Pelli-Robson)
- Natural Progression of LSCD as Assessed by Anatomical/Structural ChangesScreening through Week 84
Change in area of central cornea conjunctivalization